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RSS FeedPosted by Michael Wonder on 19 Jul 2025
Bio-Thera Solutions announces FDA accepts biologics license application for BAT2506, a proposed biosimilar to Simponi
16 July 2025 - Bio-Thera Solutions today announced that the US FDA has accepted its biologics license application for BAT2506, a ...
Posted by Michael Wonder on 18 Jul 2025
Genentech provides update on supplemental biologics license application for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
18 July 2025 - Genentech announced today that the US FDA issued a complete response letter for Genentech’s supplemental biologics ...
Posted by Michael Wonder on 18 Jul 2025
Aldeyra Therapeutics announces FDA acceptance for review of reproxalap new drug application for the treatment of dry eye disease
17 July 2025 - PDUFA target action date 16 December 2025. ...
Posted by Michael Wonder on 18 Jul 2025
Johnson & Johnson receives US FDA priority review for TAR-200 NDA in high-risk non-muscle invasive bladder cancer
17 July 2025 - New drug application supported by results from the Phase 2b SunRISe-1 study. ...
Posted by Michael Wonder on 18 Jul 2025
Praxis Precision Medicines receives FDA breakthrough therapy designation for relutrigine for the treatment of seizures associated with SCN2A and SCN8A developmental and epileptic encephalopathies
17July 2025 - The breakthrough therapy designation was granted based on the highly compelling results from the Phase 2 EMBOLD trial ...
Posted by Michael Wonder on 18 Jul 2025
Pierre Fabre announces transfer of investigational new drug application for tabelecleucel from Atara Biotherapeutics
15 July 2025 - Pierre Fabre Laboratories is now responsible for all global clinical trial activities for the tabelecleucel clinical program. ...
Posted by Michael Wonder on 17 Jul 2025
Enhertu plus pertuzumab granted breakthrough therapy designation in the US as first-line therapy for patients with HER2 positive metastatic breast cancer
17 July 2025 - Ninth breakthrough therapy designation for Daiichi Sankyo and AstraZeneca’s Enhertu with the latest based on DESTINY-Breast09 ...
Posted by Michael Wonder on 17 Jul 2025
US FDA approves GSK’s Shingrix in a pre-filled syringe presentation
17 July 2025 - Pre-filled syringe presentation offers a convenient administration option to health care professionals. ...
Posted by Michael Wonder on 16 Jul 2025
Sanofi’s SAR446597 earns fast track designation in the US for geographic atrophy due to age-related macular degeneration
16 July 2025 - The US FDA has granted fast track designation to SAR446597, a one-time intravitreal gene therapy for ...
Posted by Michael Wonder on 16 Jul 2025
FDA embraces radical transparency by publishing complete response letters
10 July 2025 - The US FDA today published more than 200 decision letters, known as complete response letters. ...
Posted by Michael Wonder on 16 Jul 2025
Nanoscope Therapeutics initiates rolling submission of biologics license application to FDA for MCO-010, the first gene-agnostic therapy to treat retinitis pigmentosa
14 July 2025 - First modules of biologics license application submitted to FDA under rolling review, with full submission anticipated ...
Posted by Michael Wonder on 16 Jul 2025
Corcept submits new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer
14 July 2025 - Corcept Therapeutics has submitted a new drug application to the US FDA for its proprietary, selective ...
Posted by Michael Wonder on 15 Jul 2025
Egetis receives FDA breakthrough therapy designation for tiratricol for MCT8 deficiency
15 July 2025 - Egetis Therapeutics today announced that the US FDA has granted breakthrough therapy designation for tiratricol, as ...
Posted by Michael Wonder on 15 Jul 2025
Taxis Pharmaceuticals earns FDA QIDP designation for TXA14007, an investigational efflux pump inhibitor to combat antibiotic resistant pneumonia
15 July 2025 - Taxis Pharmaceuticals announced today that it has received an FDA qualified infectious disease product designation for TXA14007, ...
Posted by Michael Wonder on 15 Jul 2025
Biocon Biologics expands diabetes portfolio with FDA approval of Kirsty, the first and only interchangeable rapid acting insulin aspart in the US
15 July 2025 - Biocon Biologics today announced that the US FDA has approved Kirsty (insulin aspart-xjhz), 100 units/mL as the ...